• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 08/01/2021
Event Type  Injury  
Manufacturer Narrative

Other relevant device(s) are: product id: 977a175, serial/lot #: (b)(4), ubd: 14-may-2023, udi#: (b)(4); product id: 977a175, serial/lot #: (b)(4), ubd: 14-may-2023, udi#: (b)(4). Report source: foreign: (b)(6). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that there was a sign of infection in the ins pocket region/lateral abdomen region. Device settings were not specified. No x-ray images were available. There were no environmental/external/patient factors in particular that may have led or contributed to the issue. No diagnostic/troubleshooting in particular were performed. A device system explant was planned for (b)(6) 2021, and the issue was not yet resolved. The physician's observation about severity was not severe, and the physician's observation about causality was unknown. The patient was primarily/originally treated for intractable pain.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12393520
MDR Text Key269008265
Report Number3004209178-2021-13161
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/14/2021
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/14/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/31/2021 Patient Sequence Number: 1
-
-